NCT07744022

Brief Summary

Introduction: Childhood obesity can impair postural control, balance, and motor skills, thereby limiting participation in physical activity. Aerobic exercise is widely used to improve cardiovascular fitness and support weight management in children with obesity. In recent years, however, Progressive Neuromuscular Stabilization (PNS) exercises, which aim to retrain the neuromuscular system, have been suggested to have beneficial effects on core stability, balance, and postural control. Technology-assisted exercise interventions may increase children's participation and enhance motivation throughout the rehabilitation process. This study aims to compare the effectiveness of technology-assisted PNS exercises with conventional aerobic exercise in children with obesity. Methods: This study will be conducted among children attending the Department of Pediatrics, Istanbul University-Cerrahpaşa who meet the eligibility criteria. Children aged 12-18 years with obesity will be recruited. Participants will be randomly allocated into three groups: the Aerobic Exercise (AE) group, the Progressive Neuromuscular Stabilization (PNS) group, and the Control group. Participants in the exercise groups will receive supervised exercise sessions twice weekly for 12 weeks in a clinical setting and will be instructed to perform home-based exercises on the remaining days. Home exercise programs will be delivered through the BeCure® mobile application, where exercise videos will be uploaded, and participants will be asked to perform progressively advancing exercises on a weekly basis. The control group will receive a single session of exercise counseling. Outcome assessments will be performed before and after the intervention. Sample Size: The sample size was calculated using G\*Power version 3.1. Based on moderate effect sizes reported in the literature (Lengkana et al., 2019), the effect size was set at f = 0.30, with a significance level of α = 0.05 and statistical power of 1 - β = 0.95. Power analysis for a repeated-measures design with three groups and two measurement time points (baseline and post-intervention) indicated a minimum total sample size of 48 participants. To account for potential dropouts, a total of 54 participants will be recruited. Participants will be assigned to the study groups using block randomization stratified by age and sex. Primary Outcome Measure: Balance and postural control will be assessed using the Biodex Balance System. Secondary Outcome Measures: Body composition will be evaluated using Body Mass Index (BMI), triceps and subscapular skinfold thickness, waist circumference, and Bioelectrical Impedance Analysis (BIA) to determine body fat percentage. Core muscle endurance will be assessed using the Prone Plank Test and the Side Plank Test. Functional performance will be evaluated using the 6-Minute Walk Test (6MWT), the 30-Second Sit-to-Stand Test (30-s STS), and the 20-Meter Shuttle Run Test. Physical activity level will be assessed using the Physical Activity Questionnaire for Children (PAQ-C). Self-perception and body image will be evaluated using the Self-Perception Profile for Children (SPPC). Health-related quality of life will be assessed using the Pediatric Quality of Life Inventory (PedsQL), while fatigue will be evaluated using the PedsQL Multidimensional Fatigue Scale. Posture will be assessed using the New York Posture Rating Scale. Study Plan: Each exercise session will last approximately 40 minutes, consisting of a 5-minute warm-up, 30 minutes of the main exercise program, and a 5-minute cool-down.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
54

participants targeted

Target at P25-P50 for not_applicable

Timeline
13mo left

Started Jul 2026

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress8%
Jul 2026Aug 2027

Study Start

First participant enrolled

July 3, 2026

Completed
23 days until next milestone

First Submitted

Initial submission to the registry

July 26, 2026

Completed
9 days until next milestone

First Posted

Study publicly available on registry

August 4, 2026

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 15, 2027

Expected
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 15, 2027

Last Updated

August 4, 2026

Status Verified

August 1, 2026

Enrollment Period

7 months

First QC Date

July 26, 2026

Last Update Submit

August 2, 2026

Conditions

Keywords

childhood obesity

Outcome Measures

Primary Outcomes (3)

  • Change in Overall Stability Index (OSI)

    Overall postural stability will be assessed using the Biodex Balance System. Lower scores indicate better postural stability.

    Baseline and post-intervention (Week 12)

  • Change in Anterior-Posterior Stability Index (APSI)

    Anterior-posterior postural stability will be assessed using the Biodex Balance System. Lower scores indicate better stability.

    Baseline and post-intervention (Week 12)

  • Change in Medial-Lateral Stability Index (MLSI)

    Medial-lateral postural stability will be assessed using the Biodex Balance System. Lower scores indicate better stability.

    Baseline and post-intervention (Week 12)

Secondary Outcomes (14)

  • Change in Body Mass Index

    Baseline and post-intervention (Week 12)

  • Change in Waist Circumference

    Baseline and post-intervention (Week 12)

  • Change in Skinfold Thickness

    Baseline and post-intervention (Week 12)

  • Change in Body Fat Percentage

    Baseline and post-intervention (Week 12)

  • Change in Prone Plank Duration

    Baseline and post-intervention (Week 12)

  • +9 more secondary outcomes

Study Arms (3)

Progressive Neuromuscular Stabilization (PNS) Exercise Group

EXPERIMENTAL

Participants assigned to the Progressive Neuromuscular Stabilization (PNS) group will participate in a 12-week exercise program consisting of supervised clinical sessions twice weekly and technology-assisted home-based exercises on the remaining weekdays. The exercise program will progressively target diaphragmatic breathing, core stabilization, neuromuscular coordination, balance, postural control, proprioception, and functional movement patterns. Exercise difficulty will gradually increase by incorporating unstable surfaces, resistance exercises, dual-task activities, and dynamic functional tasks. Home exercises will be delivered through the BeCure® mobile application using progressively updated instructional videos. Intervention Behavioral: Progressive Neuromuscular Stabilization Exercise A progressive neuromuscular exercise program designed to improve core stability, postural control, balance, proprioception, and neuromuscular coordination through supervised and home-based exerc

Other: Progressive Neuromuscular Stabilization Exercise

Aerobic Exercise Group

EXPERIMENTAL

Participants assigned to the aerobic exercise group will complete a 12-week exercise program consisting of supervised clinical sessions twice weekly and home-based aerobic exercise on the remaining weekdays. The intervention will include age-appropriate aerobic activities such as walking, stepping exercises, dynamic movement games, rhythmic exercises, and interval training. Exercise intensity will be progressively increased according to participants' functional capacity. Home exercise sessions will be delivered through the BeCure® mobile application using weekly exercise videos. Intervention Aerobic Exercise A progressive aerobic exercise program designed to improve cardiovascular fitness, physical activity level, functional capacity, and body composition through supervised and home-based exercise over a 12-week period.

Other: Aerobic Exercise

Control Group

NO INTERVENTION

Participants assigned to the control group will receive a single standardized exercise counseling session at baseline regarding healthy lifestyle behaviors and physical activity recommendations. No supervised exercise intervention or structured home exercise program will be provided during the 12-week study period. Participants will continue their usual daily activities. Intervention Control Group Participants will receive a one-time standardized counseling session including education on healthy lifestyle behaviors, physical activity recommendations, and obesity management.

Interventions

Aerobic Exercise Participants will complete a 12-week aerobic exercise program consisting of supervised clinical sessions twice weekly and home-based exercises delivered through the BeCure® mobile application. The program includes progressive aerobic activities aimed at improving cardiovascular fitness, physical activity level, and body composition.

Aerobic Exercise Group

Progressive Neuromuscular Stabilization Exercise Participants will complete a 12-week Progressive Neuromuscular Stabilization (PNS) exercise program consisting of supervised clinical sessions twice weekly and home-based exercises delivered through the BeCure® mobile application. The program is designed to improve core stability, balance, postural control, and neuromuscular coordination through progressively challenging exercises.

Progressive Neuromuscular Stabilization (PNS) Exercise Group

Eligibility Criteria

Age12 Years - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Aged 12 to 18 years
  • Classified as having Class I obesity (Body Mass Index \[BMI\] ≥95th percentile and \<120% of the 95th percentile for age and sex) or Class II obesity (BMI ≥120% and \<140% of the 95th percentile for age and sex), according to the Centers for Disease Control and Prevention (CDC) age- and sex-specific growth charts.
  • Able to maintain a single-leg stance on the non-dominant leg with eyes closed for less than 30 seconds.
  • Written informed consent provided by a parent or legal guardian, and assent obtained from the participant.
  • Willing and able to participate in the study.

You may not qualify if:

  • Classified as having Class III obesity (Body Mass Index \[BMI\] ≥140% of the 95th percentile for age and sex).
  • Presence of an orthopedic condition that would prevent participation in the exercise program.
  • History of any injury or surgery within the previous 6 months.
  • Presence of a chronic neurological disorder.
  • Presence of a psychiatric disorder.
  • Presence of a severe cognitive impairment.
  • Presence of cardiovascular disease.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Istanbul University- Cerrahpasa

Istanbul, Turkey (Türkiye)

RECRUITING

Related Publications (3)

  • Men J, Wang P, Gao Q, Li Y, Zhu G, Yu Z, Wu S, Zhang Y, An W, Wang J, Wu Y, Li Z, Zhang J. Impact of exercise on anthropometric outcomes in children and adolescents with overweight or obesity: a systematic review and meta-analysis based on 113 randomized controlled trials worldwide. BMC Public Health. 2025 Jul 7;25(1):2400. doi: 10.1186/s12889-025-23413-9.

    PMID: 40624670BACKGROUND
  • Bataweel EA, Ibrahim AI. Balance and musculoskeletal flexibility in children with obesity: a cross-sectional study. Ann Saudi Med. 2020 Mar-Apr;40(2):120-125. doi: 10.5144/0256-4947.2020.120. Epub 2020 Apr 2.

    PMID: 32241174BACKGROUND
  • Kc S, Goyal M, Sharma S, Goyal K. Balance training exercises and postural control in overweight and obese children: A systematic review. J Bodyw Mov Ther. 2025 Jun;42:344-351. doi: 10.1016/j.jbmt.2024.12.036. Epub 2024 Dec 28.

    PMID: 40325690BACKGROUND

Related Links

MeSH Terms

Conditions

Pediatric ObesityMotor Activity

Interventions

Exercise

Condition Hierarchy (Ancestors)

ObesityOverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsBehavior

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Emine Dilek Kurbaloğlu, PhD Student

    Istanbul University - Cerrahpasa

    STUDY CHAIR

Central Study Contacts

Emine Dilek Kurbaloğlu, PhD Student

CONTACT

Ela Tarakcı, Professor

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: This is a single-center, three-arm, parallel-group randomized controlled trial. Eligible children with obesity will be randomly assigned to either a Progressive Neuromuscular Stabilization (PNS) exercise group, an Aerobic Exercise (AE) group, or a control group using age- and sex-stratified block randomization. The intervention groups will participate in a 12-week supervised and home-based exercise program, while the control group will receive exercise counseling only. Outcomes will be assessed at baseline and after the intervention.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

July 26, 2026

First Posted

August 4, 2026

Study Start

July 3, 2026

Primary Completion (Estimated)

January 15, 2027

Study Completion (Estimated)

August 15, 2027

Last Updated

August 4, 2026

Record last verified: 2026-08

Data Sharing

IPD Sharing
Will not share

Individual participant data collected during this study will not be made publicly available because the study involves minors and contains sensitive personal and health information.

Locations